Gardasil™ Vaccine Syringe

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

SOLUTION, STERILE

**III. DOSAGE AND ADMINISTRATION** _Dosage_ GARDASIL should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule: First dose: at elected date Second dose: 2 months after the first dose Third dose: 6 months after the first dose Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Alternatively, in individuals 9 through 13 years of age, GARDASIL can be administered according to a 2-dose (0, 6 months) schedule. The use of GARDASIL should be in accordance with official recommendations. It is recommended that individuals who receive a first dose of GARDASIL complete the vaccination course with GARDASIL. The need for a booster dose has not been established. The duration of protection is currently unknown. _Method of Administration_ GARDASIL should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. GARDASIL must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended. The prefilled syringe is for single use only and should not be used for more than one individual. For single-use vials a separate sterile syringe and needle must be used for each individual. The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. After thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Discard the product if particulates are present or if it appears discolored. Single-dose Vial Use Withdraw 0.5-mL of vaccine from the single-dose vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents. Once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded. Prefilled Syringe Use Inject the entire contents of the syringe.